Newsfeeds Archive - Page 12 of 15

1 minute read

Enanta Shares Rise On Positive Data From Initial-Stage Covid Study

July 29, 11:32 AM

Enanta Pharmaceuticals (NASDAQ: ENTA) reported positive topline data from a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of orally administered single and multiple ascending doses of EDP-235 in healthy adult subjects.

ENTA

1 minute read

Omeros Shares Climb As FDA Grants Orphan Drug Status To Blood Disorder Candidate

By Ragothaman Srinivasan

July 29, 10:06 AM

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Omeros Corporation’s (NASDAQ: OMER) lead asset OMS906 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

OMER

3 minute read

Recap Of Thursday’s Biotech Catalysts – End of The Day Summary

By Ragothaman Srinivasan

July 28, 6:38 PM

Cyclerion Therapeutics (NASDAQ:CYCN) announced positive topline data from its clinical study of CY6463 for the treatment of Cognitive…

ACER

4 minute read

Recap of Wednesday’s Biotech Catalysts – End of The Day Summary

By Ragothaman Srinivasan

July 27, 7:00 PM

IDEAYA Biosciences (NASDAQ:IDYA) has entered into a clinical trial collaboration and supply agreement with Amgen Inc. to evaluate…

ABBV

1 minute read

Cidara Pursues FDA Approval For Bloodstream Infections Candidate

By Ragothaman Srinivasan

July 27, 10:35 AM

Cidara Therapeutics, Inc. (NASDAQ: CDTX) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead asset Rrezafungin for the treatment of candidemia and invasive candidiasis.

CDTX

4 minute read

Recap Of Tuesday’s Biotech Catalysts – End of The Day Summary

By Ragothaman Srinivasan

July 26, 6:24 PM

European Commission (EC) has approved AbbVie’s (NYSE:ABBV) lead asset RINVOQ (upadacitinib 45 mg [induction dose] and 15 mg…

ABBV

1 minute read

Oramed Accomplishes 50 Percent Enrolment In Late-Stage Oral Insulin Study

By Ragothaman Srinivasan

July 26, 11:12 AM

Oramed Pharmaceuticals (NASDAQ: ORMP) has enrolled over 50 percent of the planned 450 patients for its international multicenter Phase 3 ORA-D-013-2 trial of oral insulin capsule, ORMD-0801, for the treatment of type 2 diabetes (T2D).

ORMP

1 minute read

Clearside Biomedical Sees Initial-Stage Chronic Eye Disorder Study Results In Q4 2022

By Ragothaman Srinivasan

July 26, 10:42 AM

Clearside Biomedical (NASDAQ: CLSD) has completed dosing in Cohorts 3 and 4 of OASIS study of its lead drug CLS-AX (axitinib injectable suspension) in patients with neovascular age-related macular degeneration (wet AMD).

CLSD

1 minute read

HOOKIPA Gets FDA Nod For Initial-Stage Prostate Cancer Study

By Ragothaman Srinivasan

July 25, 11:49 AM

The U.S. Food and Drug Administration (FDA) has accepted HOOKIPA Pharma’s (NASDAQ: HOOK) Investigational New Drug (IND) application for HB-300, a novel arenaviral immunotherapy for the treatment of metastatic castration-resistant prostate cancer.

HOOK

1 minute read

FDA Accepts AstraZeneca’s Submission For Low Breast Cancer Candidate Under Priority Review

By Ragothaman Srinivasan

July 25, 10:21 AM

The United States Food and Drug Administration (FDA) has accepted to review the supplemental Biologics License Application (sBLA) of AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo’s lead asset ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable

AZN